Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT00517777

First received: August 15, 2007

Last updated: NA

Last verified: August 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 15, 2007

Last Updated Date

August 15, 2007

Start Date ^ICMJE

August 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

metabolic syndrome [ Time Frame: one year ]
left ventricular mass [ Time Frame: one year ]
diastolic function [ Time Frame: one year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

Official Title ^ICMJE

Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome

Brief Summary

To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sleep Apnea Syndrome
Metabolic Syndrome
Cardiac Remodelling
Continuous Positive Airway Pressure Ventilation

Intervention ^ICMJE

Device: continuous positive airway pressure ventilation
nighttime
Behavioral: dietary and life style recommendations

Study Arm (s)

Experimental: 1
continuous positive airway pressure ventilation + dietary and life style recommendations
Interventions:
- Device: continuous positive airway pressure ventilation
- Behavioral: dietary and life style recommendations
Active Comparator: 2
dietary and life style recommendations

Intervention: Behavioral: dietary and life style recommendations

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

August 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

moderate to severe sleep apnea syndrome

Exclusion Criteria:

cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
thyroid diseases
diabetes

Gender

Both

Ages

25 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00517777

Other Study ID Numbers ^ICMJE

1113

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Università degli Studi dell'Insubria

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

anna maria grandi, MD

Università degli Studi dell'Insubria

Information Provided By

Università degli Studi dell'Insubria

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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